Obesity and Overweight
Conditions
Brief summary
This clinical trial aims to determine whether BK329 reduces body fat in adults with overweight or obesity and to assess its safety. The main questions are: * Does BK329 reduce body fat in participants? * What side effects occur when participants take BK329?
Detailed description
Researchers will compare BK329 to a placebo to evaluate its effectiveness in reducing body fat. Participants will: * Take BK329 or a placebo daily for 12 weeks. * Visit the clinic every six weeks for checkups and tests.
Interventions
DIETARY_SUPPLEMENTBK329
Lactococcus lactics. subsp. lactis CAB701(KCCM13360P) 400 mg/day for 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo 400 mg/day for 12 weeks
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* individuals with a Body Mass Index (BMI) between 23 and 30 kg/m2. * Individuals who have provided written consent on the consent form.
Exclusion criteria
* Subjects with severe cerebrovascular disease (e.g., stroke, cerebral hemorrhage), heart disease (e.g., angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant tumors within the last 6 months. (However, subjects with a history of these diseases who are clinically stable may participate at the investigator's discretion.) * Uncontrolled hypertensive patients (blood pressure ≥160/100mmHg, measured after 10 minutes of rest). * Diabetic patients with poor blood glucose control (fasting glucose ≥160mg/dL). * Subjects undergoing treatment for hypothyroidism or hyperthyroidism. * Subjects with creatinine levels ≥ 2 times the upper limit of the research institution's normal range. * Subjects with aspartate transaminase or alanine transaminase levels ≥ 3 times the upper limit of the research institution's normal range. * Subjects experiencing severe gastrointestinal symptoms such as heartburn or indigestion (lactose intolerance). * Subjects who have taken weight-altering drugs (absorption inhibitors, appetite suppressants, obesity-related supplements, psychiatric drugs, beta-blockers, diuretics, contraceptives, steroids, or female hormones) within the last month. * Subjects who have participated in commercial weight loss programs within the last 3 months. * Subjects who have participated in or plan to participate in another clinical trial within the last month. * Alcohol abusers. * Subjects who quit smoking within the last 3 months. * Pregnant or breastfeeding women or those planning pregnancy during the trial period. * Subjects with allergies to any components of the study foods. * Subjects deemed inappropriate for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total body fat (kg) | 12 weeks | Using dual-energy X-ray absorptiometry at baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean body mass (kg) | 12 weeks | Using dual-energy X-ray absorptiometry at baseline and 12 weeks |
| Body mass index (kg/m2) | 12 weeks | Measured at baseline and 12 weeks |
| Body weight (kg) | 12 weeks | Measured at baseline and 12 weeks |
| Waist-to-hip ratio | 12 weeks | Measured at baseline and 12 weeks |
| Total cholesterol level (mg/dl) | 12 weeks | Measured at baseline and 12 weeks |
| Triglycerides level (mg/dL) | 12 weeks | Measured at baseline and 12 weeks |
| Body fat percentage | 12 weeks | Using dual-energy X-ray absorptiometry at baseline and 12 weeks |
| Low-density lipoprotein cholesterol levels (mg/dL) | 12 weeks | Measured at baseline and 12 weeks |
| Free fatty acid level (mg/dL) | 12 weeks | Measured at baseline and 12 weeks |
| High-sensitivity C-reactive protein (mg/dL) | 12 weeks | Measured at baseline and 12 weeks |
| Total immunoglobulin E level (IU/mL) | 12 weeks | Measured at baseline and 12 weeks |
| Neutrophil-to-lymphocyte ratio | 12 weeks | Measured at baseline and 12 weeks |
| High-density lipoprotein cholesterol levels (mg/dL) | 12 weeks | Measured at baseline and 12 weeks |
Countries
South Korea
Outcome results
None listed